{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
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  "results": [
    {
      "cfres_id": "215029",
      "product_res_number": "Z-2288-2025",
      "event_date_initiated": "2025-07-15",
      "event_date_posted": "2025-08-11",
      "recall_status": "Open, Classified",
      "res_event_number": "97275",
      "product_code": "JDG",
      "k_numbers": [
        "K953653"
      ],
      "product_description": "Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.",
      "code_info": "Item Number: 198-828/04. UDI-DI: 04026575193783. Serial Numbers: 211117/0069, 211117/0070, 211117/0071, 211117/0073, 211117/0078, 220204/0613, 220204/0614, 220204/0615, 220204/0616, 220204/0617, 220204/0618, 220204/0619, 220204/0620, 220204/0621, 220204/0622, 220204/0623, 220204/0624, 220204/0627, 220304/0074, 220304/0075, 220304/0076, 220304/0077, 220304/0078, 220304/0080, 220304/0081, 220304/0082, 220304/0083, 220517/0052, 220517/0069, 220517/0070, 220517/0071, 220517/0072, 220517/0073, 220517/0074, 220517/0076, 220517/0078, 220517/0079, 220517/0080, 220517/0081, 220517/0085, 220517/0088, 220517/0089, 220517/0090, 221011/0093, 240415/3890, 240415/3896.",
      "firm_fei_number": "3003386935",
      "recalling_firm": "Waldemar Link GmbH & Co. KG (Mfg Site)",
      "address_1": "Oststr. 4-10 4-10 oststr.",
      "city": "Norderstedt",
      "country": "Germany",
      "additional_info_contact": "Jennifer Lubrecht\n862-477-0370",
      "reason_for_recall": "Inconsistent size terminology and color coding used on labeling",
      "root_cause_description": "Under Investigation by firm",
      "action": "Waldemar Link GmbH & Co. notified consignees of the recall via email on about 07/15/2025.  Consignees were instructed to respond using the Distributor Reply form and arrange for the return of all affected product on hand.",
      "product_quantity": "46 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.",
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        "device_name": "Prosthesis, Hip, Femoral Component, Cemented, Metal",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3360",
        "device_class": "2"
      }
    }
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}